What is remdesivir? Gilead Sciences drug reportedly shows promise treating coronavirus
mIn this March 2020 photo provided by Gilead Sciences, rubber stoppers are placed onto filled vials
of the investigational drug remdesivir at a Gilead manufacturing site in the United States.AP
Remdesivir is causing “rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week” in patients at a Chicago hospital, medical site STAT reported.
The story contributed to a surge in stocks Friday and a jump in Gilead’s stock price, which rose 8.1% to $82.74 at 10:14 a.m.
“The entire world has been waiting for results from Gilead’s clinical trials, and positive results would likely lead to fast approvals by the Food and Drug Administration and other regulatory agencies,” STAT reported. “If safe and effective, it could become the first approved treatment against the disease.”
Remdesivir is one of numerous drugs under development to treat or cure the coronavirus. Clinical trials are conducted to ensure safety and efficacy, and there’s no guarantee the Chicago hospital’s results will be replicated elsewhere.
The results came from the University of Chicago Medicine, which is participating in two Gilead clinical trials involving 2,400 severe cases at 152 sites and 1,600 moderate cases at 169 sites, according to STAT. The University of Chicago data covered 125 people infected with COVID-19, including 113 severe cases, all of whom are being given daily doses.
STAT reported the news based on a video of trial leaders discussing the early results.
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Evercore ISI drug industry analyst Umer Raffat wrote late Thursday in a research note that it’s “not a silver bullet” but there’s reason to be “cautiously optimistic.”
Gilead spokesperson Chris Ridley said the company expects to receive results from the study of severe cases at the end of April, followed by other results in May.
“We understand the urgent need for a COVID-19 treatment and the resulting interest in data on our investigational antiviral drug remdesivir,” Ridley said in an email. “The totality of the data need to be analyzed in order to draw any conclusions from the trial. Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of remdesivir as a treatment for COVID-19.”
Medical professionals have had high hopes for remdesivir since the coronavirus pandemic began.
Other studies have shown promising results, as well, albeit with fewer patients.
The New England Journal of Medicine on Friday published the results of a 10-day study involving 53 “quite severe” patients in which 68% showed “clinical improvement,” 47% were discharged before the study was completed and 13% died, according to UBS analyst Navin Jacob.
“Ultimately if remdesivir does prove effective, we think it is likely to be best suited for treating hospitalized patients and unlikely as a prophylactic therapy given some unknowns on safety,” Jacob wrote Monday in a research note. “Nonetheless an effective treatment that reduces the need for ICU beds, speeds up discharges, & reduces mortality could hypothetically provide relief to the (health care) system.”
Remdesivir, the result of more than a decade of Gilead research, has been tested for multiple potential applications in recent years. The company tested the drug as a treatment for Ebola in west Africa in 2014. It has also been tested as a treatment of SARS and for hepatitis C.
If remdesivir were approved by the FDA, Gilead hopes to start manufacturing quickly.
“In anticipation of potential future needs, we have accelerated manufacturing timelines to increase our available supply as rapidly as possible,” Gilead says in a fact sheet about the drug. “We are doing this before knowing whether remdesivir will be determined to be safe and effective to treat patients with COVID-19.”
Contributing: Grace Hauck